Hetero Labs Ltd, a global leader in APIs, is hiring Regulatory Affairs professionals for its Hyderabad facility. With USFDA and EUGMP approvals, Hetero exports to 145+ countries, generating ₹8,000 Crore revenue. Rated 3.8/5 on AmbitionBox for job security, it scores lower (3.4/5) for work-life balance. This role offers ₹4–10 Lakhs per annum, per Indeed.
Application Details
- Location: Hetero Labs Ltd, Unit-V, Polepally, Jadcherla, Mahbubnagar, Hyderabad, Telangana 509301
- Apply: Email CV to prathap.p@hetero.com, subject: “RA API – Hyderabad”
- Deadline: May 15, 2025
- Contact: prathap.p@hetero.com
- Website: www.hetero.com
Notes:
- Fraud Alert: Hetero does not charge fees. Verify via www.hetero.com.
- Confirm work-life balance, as 25% of reviews cite long hours.
Why Join Hetero?
Hetero, founded in 1993, employs 20,000+ and produces APIs like Sofosbuvir at its Hyderabad facility. With zero recent USFDA 483s, it ensures cGMP compliance. Skill development is rated 3.9/5, but salary transparency scores 3.5/5. Join a $24.4 billion Indian pharma export leader.
Job Position: Regulatory Affairs – API
Seeking candidates to manage regulatory submissions for APIs, ensuring compliance with global standards.
Job Details
- Department: Regulatory Affairs – API
- Qualification: M.Sc (Organic Chemistry), M.Pharm, B.Pharm
- Experience: 2–8 years in API regulatory affairs
- Location: Hyderabad, Telangana
- Employment: Full-time
Key Responsibilities
- Compile DMFs and CEPs for US, EU, Brazil, China, LATAM, and ICH markets.
- Submit regulatory dossiers per eCTD standards.
- Update documentation to meet evolving regulatory requirements.
- Handle filings, amendments, and annual reports for compliance.
- Participate in deficiency meetings and resolve pending issues.
- Review documents, ensure cGMP compliance, and support audits.
- Manage international regulatory projects aligned with company goals.
- Enhance regulatory procedures and documentation practices.
Required Skills and Qualifications
| Category | Details |
|---|---|
| Education | M.Sc (Organic Chemistry), M.Pharm, B.Pharm |
| Experience | 2–8 years in API RA, with DMF/CEP compilation |
| Technical Skills | Expertise in eCTD, DMF, CEP filings, amendments |
| Regulatory Knowledge | US, EU, ICH, Brazil, China regulations |
| Soft Skills | Detail-oriented, organizational, coordination, and multitasking |
| Preferred Expertise | Experience with QMS, LIMS, or audit support |
Why This Role?
- Global Impact: Support APIs for 145+ countries, enhancing your RA expertise.
- Skill Growth: Master eCTD and ICH guidelines, rated 3.9/5 for learning.
- Stable Employer: Work in a USFDA-approved facility, though verify work hours.
- Competitive Pay: ₹4–10 Lakhs per annum with benefits, per AmbitionBox.
How to Apply
- Prepare: Update CV, include 2–8 years RA experience, certificates, payslips, ID proof.
- Submit: Email to prathap.p@hetero.com, subject: “RA API – Hyderabad.”
- Details: Mention experience, current/expected CTC, notice period.
- Interview Prep: Study DMF, CEP, ICH Q7; address work-life balance concerns.
- Research: Visit www.hetero.com for API portfolio (e.g., Dolutegravir).
Why Hyderabad, Telangana?
Hyderabad, India’s pharma capital, hosts Hetero’s Unit-V in Jadcherla. With 800+ firms, Telangana’s $10 billion pharma sector grows at 15% CAGR. Connected via NH-44, Hyderabad offers a vibrant ecosystem for pharma careers.
Contact Information
- Email: prathap.p@hetero.com
- Address: Hetero Labs Ltd, Unit-V, Polepally, Jadcherla, Mahbubnagar, Hyderabad, Telangana 509301
- Corporate: Hetero Corporate Office, 7-2-A2, Industrial Estate, Sanath Nagar, Hyderabad, Telangana 500018
- Phone: +91-40-23704923
- Website: www.hetero.com
- LinkedIn: Hetero
Join Hetero Labs to drive global API compliance. Apply by May 15, 2025, and ensure a balanced, rewarding career!
